Kornimate/medical-research-clean huggingface dataset:
post- rotatory nystagmus test: normative data for spanish adolescents and adults

Conditions: Vestibular Function Tests; Nystagmus Vestibular

Summary: the vestibulo-ocular reflex is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. the post-rotational nystagmus test (prn) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. the duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. however, there is a knowledge gap from that age that the present study seeks to address.

the vestibulo-ocular reflex (vor) is the motor response of our eyes in the opposite direction to a translational or rotational movement of our head. the post-rotational nystagmus test (prn) assesses the integrity of this reflex, thus assessing the perception of the vestibular system. this system has an important role in our balance, stabilization of the visual field when our head moves, awareness of the position of our head in space, postural control and functions of the autonomous nervous system. the duration of this reflex after administering this test has been widely studied in children from 2 months to 12 years and 11 months of age. however, there is a knowledge gap from that age that the present study seeks to address. this article aims to explore the use of the prn test for adolescent and adults, to prove if the duration of the vor is longer in these population than in children. it will be also recollected personal data to study whether exposure to vestibular input influences its reactivity and perception.

Eligibility criteria:
inclusion criteria: * people over 13 years of age. * spanish-speaking population. * signature of the informed consent. exclusion criteria: * diagnosis of a neurodevelopmental or neurological disorder. * being in occupational therapeutic treatment for balance or vestibular problems. * practice of sports in one previous hour. * adverse reaction to vestibular input such as vomiting, discoloration, feeling of unpleasantness or any other type of negative reaction before / during / after the administration of the npr.

Keywords: vestibular function tests nystagmus, physiologic adult adolescent
vocale lbd+ for caregivers of persons with lewy body dementia

Conditions: Caregiver Burden; Lewy Body Disease; Stress; Skill, Coping

Summary: the goal of this clinical trial is to evaluate the feasibility, acceptability, and initial efficacy of the vocale lbd+ intervention in caregivers of persons living with lewy body dementia. the main question\[s\] it aims to answer are: * what is the extent to which the vocale lbd+ intervention affects caregiving mastery scores at the end of the eight-week intervention * what is the extent to which a change in caregiving mastery scores is retained four weeks after the end of the vocale lbd+ intervention participants will be asked to participate in a fully online asynchronous vocale lbd+ intervention that involves a moderated web-based discussion platform, peer-to-peer support, didactic training, and problem-solving skill enactment.


Eligibility criteria:
inclusion criteria: * informal and/or lay caregiver of a patient with lbd * can read, write, and speak english * has access to a device that can be used for videoconferencing and/or phone calls * 18 years or older exclusion criteria: * not an informal and/or lay caregiver * cannot read and write in english * no access to a device that can be used for videoconferencing and/or phone calls younger than 18 years old
efficacy and safety of oral bt-11 in moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: this is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.


Eligibility criteria:
key inclusion criteria: 1. subjects aged 18 to 75 years with a diagnosis of cd for at least 3 months; 2. moderately to severely active cd as defined by: a cdai score of 220 450, and an ses-cd scored ≥ 6 ( ≥ 4 for isolated ileitis) (centrally read); key exclusion criteria: 1. ulcerative colitis; 2. known current bacterial or parasitic pathogenic enteric infection; live virus vaccination within 12 weeks of screening.
electroencephalographic patterns of septic patients and its correlation with cognitive outcomes

Conditions: Sepsis

Summary: the investigators evaluated the electroencephalographic pattern by the sinek and young scales during icu stay and its correlation with cognitive impairment determined by the montreal cognitive assessment (moca) in septic patients after 3 months of icu discharge..

the investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (icu) for at least 4 days. we used sinek and young scales to classify electroencephalographic patterns during icu stay (in the first 24 hours after admission and in the third icu day) and correlate with cognitive outcome evaluated with moca score 3 months after icu discharge. the investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the montreal cognitive assessment (moca) 3 months after icu discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, quality of life (sf-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and glasgow outcome scale.

Eligibility criteria:
inclusion criteria: included were patients aged above 18 years, who were expected to stay in the icu for at least 4 days, between november 2021 and november 2022. - exclusion criteria: * cns infections, * structural abnormalities of the cns, known * liver or uremic encephalopathy, * advanced dementia (mini mental \< 9), * psychiatric disorder * epilepsy.

Keywords: eletroencephalography sepsis septic shock critical care cognitive dysfunction montreal cognitive assessment
comparison of d2 vs d3 lymph node dissection for right colon cancer (ricon)

Conditions: Colon Cancer

Summary: comparing different method of surgical technique d2 lymph node dissection vs d3 for right colon cancer.


Eligibility criteria:
inclusion criteria: 1. agreement of the patient to participate in trial 2. colon cancer (only adenocarcinoma ) 3. the tumor located between the cecum and the right 1/3 of transverse colon 4. tumors t3,т4а,b n0-2 (ii-iii stages) 5. tolerance of chemotherapy 6. ecog 0-2 exclusion criteria: 1. patients with distant metastases 2. tumors t1-2 (i stage) 3. complications of tumor (perforation and full bowel obstruction) 4. previous radiotherapy or chemotherapy 5. synchronous or metachronous tumors 6. women during pregnancy or breast feeding period

Keywords: right colon cancer d3 dissection complete mesocolic excision hemicolectomy
preserving acts - text reminders to increase adherence to act treatment

Conditions: Malaria

Summary: a randomized controlled trial was conducted to assess the effectiveness of text reminders sent to act users through an automated text messaging system short-message-system. study hypothesis: text message reminders increase adherence

a randomized controlled trial was conducted to assess the effectiveness of text reminders sent to act users through an automated text messaging system short-message-system. patients were enrolled at clinics and pharmacies upon receipt of acts and enrolled in the automated system for 3 days.

Eligibility criteria:
inclusion criteria: -subjects acquiring acts in tamale, ghana exclusion criteria: * subjects acquiring acts for non household members * subjects under the age of 18 * subjects without access to cell phones * subjects living more than 30 minutes from pickup location

Keywords: malaria acts
burning mouth syndrome mouth guard prospective study

Conditions: Burning Mouth Syndrome; Burning Mouth

Summary: this study will seek to test the effectiveness of a nonpharmacologic therapy for burning mouth syndrome (bms). this nonpharmacologic therapy approach will be the fabrication a protective acrylic mouthguard for the maxillary arch and palate.

the study involves a nonpharmacologic and non-invasive treatment method for bms which will be administered randomly (flipping a coin) to half of the study subjects, (case group) in addition to normal condition treatment protocol for bms.

Eligibility criteria:
inclusion criteria: • new patients diagnosed with bms seen in the oral medicine clinic for the study period. exclusion criteria includes: • patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding bms as a diagnosis inclusion criteria:
efficacy and safety of tacrolimus sustained-release capsules in induction treatment in refractory lupus nephritis

Conditions: Nephritis, Lupus

Summary: this a pilot study to evaluate the efficacy and safety of tacrolimus sustained-release capsules (advagraf) treatment for the induction therapy of refractory lupus nephritis (ln).


Eligibility criteria:
inclusion criteria: 1. subjects of either sex, 14-65 years of age; 2. diagnosis of sle according to the acr criteria (1997); 3. kidney biopsy within the 6 months prior to study with a histologic diagnosis (isn/rps 2003 classification of ln) class iv, v, v+ iii, v+ iv; 4. usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (aza, mmf, oral cyclophosphamide, ect) for more than 6 months; 5. proteinuria \> 1g/24hr or scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 wbc/high power field (hpf) (excluding infection), \> 5 rbc/hpf); 6. provision of written informed consent by subject or guardian exclusion criteria: 1. inability or unwillingness to provide written informed consent ; 2. usage of immunosuppression therapy (mmf, ctx, cysa, mtx etc) for more than 1 week within 1 month or intravenous mp pulse treatment prior to entry; 3. scr \> 4mg/dl (354umol/l); 4. needing pulse intravenous mp or intravenous immunoglobulin; 5. lupus encephalopathy; 6. diagnosed dm; malignant tumors (except fully cured basal cell carcinoma); 7. history of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study; 8. known hypersensitivity or contraindication to tacrolimus, corticosteroids 9. any active systemic infection or history of serious infection within one month of entry or known infection with hiv, hepatitis b, or hepatitis c; 10. participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening; 11. pregnancy, nursing or use of a non-reliable method of contraception.

Keywords: nephritis, lupus tacrolimus
lapelga vs gastrofil

Conditions: Multiple Myeloma; Lymphoma; Engagement, Patient; Febrile Neutropenia

Summary: this study is examining one-time injection of biosimilar pegfilgrastim compared with multiple injection biosimilar filgrastim post autologous hematopoietic stem cell transplantation. study aims to compare biosimilar pegfilgrastim - lapelga and biosimilar filgrastim -gastrofil to see if they are similar in efficacy in terms of neutrophil engraftment, limited adverse effects, and more convenience to our patients, with potential cost savings.

this will be a prospective open randomized controlled study. the study will be conducted in the inpatient setting at the london health sciences centre (lhsc) in london, on, and windsor metropolitan hospital (wmh) in windsor, on. the objective of the study is to assess if biosimilar peg-filgrastim similar is non-inferior to biosimilar filgrastim (lapelga versus gastrofil) in terms of neutrophil engraftment in autologous transplant patients with lymphoma and multiple myeloma. current clinical practice uses a risk-adapted approach where we use originator filgrastim - neupogen starting on day 5 for patients who are aged 60 or greater, infusion of stem cells with a cd34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the provider's clinical discretion. for the purposes of the trial, patients will be randomized to lapelga versus gastrofil arm directly and will initiate assigned treatment at day+5 of autologous transplant. both lhsc and wmh have qualified investigators (hematologists or other qualified clinicians. the study will start only after receipt of regulatory and ethics approval. screening investigations on patients will be done only after the signing of written informed consent.

Eligibility criteria:
inclusion criteria: * patients must be able and willing to give written informed consent prior to any study related procedures * patients with a diagnosis of multiple myeloma or lymphoma who are eligible for autologous stem cell transplant * all adult patients aged 18 to 75 years * all patients admitted to lhsc for autologous peripheral blood stem cell transplant receiving peripheral blood stem cell infusions at lhsc and post-transplant care at either lhsc or wmh. * of the patients who are admitted for autologous stem cell transplant, the patients that meet the risk adapted approach for gscf will be included in the study. the risk adapted criteria are aged 60 or greater, infusion of stem cells with a cd34 count less than or equal 3 x 10\^6/kg, prior episodes of febrile neutropenia, or at the providers clinical discretion * conditioning chemotherapy as per usual clinical practice exclusion criteria:patients satisfying the above inclusion criteria but with the following contraindications (prior to randomization) will be excluded from the study: * any clinical contraindications to filgrastim, e.g. hypersensitivity to g-csf or e. coli-derived proteins * pain requiring opioids with use of filgrastim during mobilization of autologous stem cells. * unable or not willing to provide written consent
facilitating engagement in evidence-based treatment for early psychosis

Conditions: Psychotic Disorders

Summary: the purpose of this mixed methods study is to evaluate a peer-delivered decision support intervention with emerging adults newly enrolled in an early intervention program, also known as coordinated specialty care (csc). it is hypothesized that participants will experience a reduction in decision-making needs after participating in the intervention, and that study and intervention procedures will demonstrate feasibility and acceptability.

the overarching goal of this study is to pilot test a peer-delivered decision support intervention (in the form of decision coaching) that is designed to enhance emerging adults' treatment decision-making and service engagement after enrollment in a coordinated specialty care (csc) program. based on an experimental therapeutics approach, this mixed methods pilot trial will assess feasibility, acceptability, and the intervention's potential impact on key decision-making needs (i.e., decision-making targets). we will track feasibility data related to study and intervention procedures, and collect acceptability and outcome data from 20 emerging adults who will participate in the intervention after enrollment in the csc program. quantitative analysis related to decision-making targets will provide preliminary evidence regarding whether the intervention impacts these targets, while qualitative analysis will explain how it may do so. merged results from these two sets of data will inform intervention refinement by providing a nuanced understanding of the intervention's potential to engage decision-making targets from the perspective of emerging adults.

Eligibility criteria:
inclusion criteria: * 18-30 years of age * experiencing early psychosis,defined as psychosis lasting 18 months or less between the time when threshold symptom criteria were reached (as determined by the admitting csc program assessor) and the date of csc program enrollment * able to speak/understand english * able to provide informed consent as assessed by research staff * enrolled in the csc program for any period of time exclusion criteria: * having a legal guardian * diagnosis of dementia, delirium, or intellectual disability as determined by the admitting csc program psychiatrist

Keywords: decision support techniques, young adult
risk stratification of vt / vf after myocardial infarction based on cardiac mri 2

Conditions: Myocardial Infarction; Ventricular Tachycardia; Ventricular Fibrillation

Summary: implantable cardioverter-defibrillators (icd) are currently recommended (esc guidelines 2015) for the primary prevention of sudden cardiac death (scd) in patients with a remote myocardial infarction (mi) and a low (≤35%) left ventricular ejection fraction (lvef). ventricular tachycardia (vt) and/or ventricular fibrillation (vf), which are responsible for most scds, result from the presence of surviving myocytes embedded within fibrotic mi-scar. the presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by lvef. consequently, most patients with a prophylactic icd do not present vt/vf requiring icd therapy prior to their first-icd battery depletion. thus, many patients are exposed to icd complications, such as inappropriate shocks, without deriving any health benefit. as a consequence, the current implantation strategy of prophylactic icds, based on lvef, needs to be improved in post-mi patients. stratification of the rhythmic risk after idm is therefore still a major public health issue. late gadolinium enhancement cardiac magnetic resonance (lge-mri) is a strong risk-stratifier of vt/vf risk in post- mi patients. in a recent multicenter retrospective study, the investigators showed that the presence of a critical surface of intramural scar (which is consequently neither epicardial nor endocardial) at the infarct border (measured by lge-mri) has a major association with the occurrence of vt/vf in post-mi patients with a lvef≤35%. the aim of the tvscreen 2 study is therefore to validate the relevance of the mri criterion in a new independent cohort of patients.


Eligibility criteria:
inclusion criteria: * person who has received full information on the organization of the research and who has not objected to the use of this data; * person having had an icd implantation for primary prevention before 12/31/2017 after myocardial infarction; * person with lvef ≤35% at the time of icd implantation. exclusion criteria: * patient with a history of persistent atrial fibrillation.
surgical treatment of cervical spondylotic myelopathy

Conditions: Cervical Spondylotic Myelopathy

Summary: the primary purposes of this study are to compare anterior and posterior surgical approach in treatment of csm ad to compare variations in treatment and outcomes of csm worldwide.


Eligibility criteria:
inclusion criteria: * age \> 18 years * willing and able to give written informed consent to participate in the study * willing and able to participate in the study follow-up according to the protocol * willing and able to comply with post-operative management program * understand and read country language at elementary level * patients who undergo surgery for symptomatic csm defined as a combination of one or more of the following symptoms: * numb hands * clumsy hands * impairment of gait * bilateral arm paresthesiae * l'hermitte's phenomena * weakness and one or more of the following signs: * corticospinal distribution motor deficits * atrophy of hand intrinsic muscles * hyperreflexia * positive hoffman sign * upgoing plantar responses * lower limb spasticity * broad based, unstable gait exclusion criteria: * asymptomatic csm * previous surgery for csm * active infection * neoplastic disease * rheumatoid arthritis * ankylosing spondylitis * trauma * concomitant symptomatic lumbar stenosis * pregnant women or women planning to get pregnant during the study period * has a history of substance abuse (recreational drugs, alcohol) * is a prisoner * is currently involved in a study with similar purpose * has a disease process that would preclude accurate evaluation (eg., neuromuscular disease, significant psychiatric disease) * patients seen by other services (eg., physical medicine, neurology, family practice), managed conservatively and not referred for surgical consultation are ineligible.
treatment of patients with non-healing wounds and trophic ulcers using autologous dermal fibroblasts

Conditions: Trophic Ulcer; Non-healing Wound; Non-Healing Ulcer of Skin

Summary: treatment of patients with non-healing wounds and trophic ulcers using local led phototherapy with local transplantation of autologous dermal fibroblasts

during the implementation of the project, it was planned to develop a method for the treatment of trophic ulcers using injection of autologous dermal fibroblasts in the wound. the positive outlook for the effectiveness of photodiode therapy with dermal fibroblasts is due to the following: * the ability of fibroblasts to stimulate tissue regeneration * positive results of preclinical studies of the method of treatment of long-term non-healing wounds in animals (rats). twelve patients were included in the study. dermal fibroblasts were isolated from the skin patients, cultured and then transplanted back to the wound. the therapeutic dose of cells was 50k per cm2 of the wound area. follow up patients monitoring was performed at 1, 2 and more months after injection.

Eligibility criteria:
inclusion criteria: * trophic ulcers * chronic non-healing wounds exclusion criteria: * acute and chronic infectious diseases: hiv, viral hepatitis, tuberculosis * mental disorders * pregnancy

Keywords: trophic ulcer non-healing wound dermal fibroblasts
a study of bbi608 in combination with temozolomide in adult patients with recurrent or progressed glioblastoma

Conditions: Glioblastoma

Summary: this is an open label, multi-center, phase 1 safety run-in and phase 2 study of bbi608 in combination with temozolomide in patients with recurrent or progressive glioblastoma who have not received prior bevacizumab therapy.

in arm a, patients who are candidates for surgical resection will receive bbi608 as monotherapy prior to resection, followed by post-operative bbi608 administered in combination with temozolomide. in arm b, patients who are not candidates for surgical resection will receive bbi608 administered orally, daily, in combination with temozolomide. in the phase 1/dose-limiting toxicity (dlt) cohort portion of this study, pharmacokinetics will be evaluated for both arms a and b. pharmacodynamics will be evaluated in all patients who undergo surgical resection.

Eligibility criteria:
major eligibility criteria 1. signed written informed consent must be obtained and documented according to international conference on harmonisation (ich) and local regulatory requirements. 2. a histologically confirmed supratentorial glioblastoma (gbm) at first recurrence/progression (except for transformation from previous low grade glioma) following standard front-line therapy, for which treatment with temozolomide (tmz) would be acceptable as determined by the investigator 3. previously received standard front-line gbm treatment including maximal surgical resection followed by external beam radiation therapy. 4. patients may or may not be candidates for repeat surgical resection of the recurrent/progressed gbm. 5. patients must have unequivocal evidence of tumor recurrence/progression by mri at a minimum of 12 weeks following completion of chemoradiation or radiation therapy. 6. patients must have measurable or non-measurable disease by response assessment in neuro-oncology response assessment in neuro-oncology (rano) criteria

Keywords: gbm malignant glioma